Vinblastine for Leukoreduction in Newly Diagnosed AML and Hyperleukocytosis

NCT05062278 | Unknown Phase 2 FDA Drug

• 1 other identifier: HE21-00019
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Vinblastine can leukoreduce patients with newly diagnosed AML and hyperleukocytosis but clinical trials are lacking.

Conditions

AML; Hyperleukocytosis

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with a significant reduction in the number of leukocytes by complete blood count

  The proportion of patients with a reduction in the number of leukocytes higher than 50% by complete blood count at 48 hours after the intervention.

  2 days

Secondary Outcomes (2)

• Description of daily leukocytes by complete blood count after intervention

  5 days

• Time to achieve a significant reduction in leukocyte count by complete blood count

  5 days

Study Arms (2)

Intravenous Vinblastine

EXPERIMENTAL

Single dose intravenous vinblastine (6mg/m2) in bolous.

Drug: Vinblastine

Oral Hydroxiurea

ACTIVE COMPARATOR

Patient will recieve oral hydroxiurea at a dose of 50mg/kg/day until response or administration of induction chemotherapy

Drug: Hydroxyurea capsules

Interventions

Vinblastine DRUG

Single-dose of intravenous vinblastine at 6mg/m2 (maximum 10mg).

Also known as: Blestinib

Intravenous Vinblastine

Hydroxyurea capsules DRUG

Oral hydroxyurea at a dose of 50mg/kg/day until the administration of induction chemotherapy.

Oral Hydroxiurea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Both genders
• Diagnosis of non-M3 AML by the WHO 2016 diagnostic criteria
• Patients eligible and not eligible for transplant
• Patients eligible and not eligible for intensive treatment
• AML secondary to treatment or associated to myelodisplasia
• Leukocytes ≥50x106/L
• Not being able to receive chemotherapy in the next two days

You may not qualify if:

• AML with PMP/RAR-alfa translocation t(15;17)
• Poor functional status (ECOG\>2)
• Active infection
• Pregnancy

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (5)

• Kuo KH, Callum JL, Panzarella T, Jacks LM, Brandwein J, Crump M, Curtis JE, Gupta V, Lipton JH, Minden MD, Sher GD, Schimmer AD, Schuh AC, Yee KW, Keating A, Messner HA. A retrospective observational study of leucoreductive strategies to manage patients with acute myeloid leukaemia presenting with hyperleucocytosis. Br J Haematol. 2015 Feb;168(3):384-94. doi: 10.1111/bjh.13146. Epub 2014 Oct 10.

  PMID: 25303497 BACKGROUND

• Marbello L, Ricci F, Nosari AM, Turrini M, Nador G, Nichelatti M, Tedeschi A, Vismara E, Morra E. Outcome of hyperleukocytic adult acute myeloid leukaemia: a single-center retrospective study and review of literature. Leuk Res. 2008 Aug;32(8):1221-7. doi: 10.1016/j.leukres.2008.01.004. Epub 2008 Mar 3.

  PMID: 18313749 BACKGROUND

• Mamez AC, Raffoux E, Chevret S, Lemiale V, Boissel N, Canet E, Schlemmer B, Dombret H, Azoulay E, Lengline E. Pre-treatment with oral hydroxyurea prior to intensive chemotherapy improves early survival of patients with high hyperleukocytosis in acute myeloid leukemia. Leuk Lymphoma. 2016 Oct;57(10):2281-8. doi: 10.3109/10428194.2016.1142083. Epub 2016 Feb 5.

  PMID: 26849624 BACKGROUND

• Salerni BL, Bates DJ, Albershardt TC, Lowrey CH, Eastman A. Vinblastine induces acute, cell cycle phase-independent apoptosis in some leukemias and lymphomas and can induce acute apoptosis in others when Mcl-1 is suppressed. Mol Cancer Ther. 2010 Apr;9(4):791-802. doi: 10.1158/1535-7163.MCT-10-0028. Epub 2010 Apr 6.

  PMID: 20371726 BACKGROUND

• Sauter C, Fehr J, Frick P, Gmuer J, Honegger H, Martz G. Acute myelogenous leukemia: successful treatment of relapse with cytosine arabinoside, VP 16-213, vincristine and vinblastine (A-triple-V). Eur J Cancer Clin Oncol. 1982 Aug;18(8):733-7. doi: 10.1016/0277-5379(82)90071-2.

  PMID: 6961036 BACKGROUND

MeSH Terms

Interventions

Vinblastine; Hydroxyurea

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Urea; Amides; Organic Chemicals

Study Officials

• David Gomez

  Universidad Autonoma de Nuevo Leon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andres Gomez

CONTACT

818470002; drgomezdeleon@gmail.com

Perla Colunga

CONTACT

colunga.perla@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hematology Department

Model Details: Patients with newly diagnose AML will be allocated 1:1 to recieve single dose vinblastine or daily oral hydroxiurea

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: September 30, 2021
• Study Start: July 26, 2021
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)